Edwards’ U.S. sales for its Sapien transcatheter heart valve were slightly lower sequentially in the third quarter, a factor that will likely “continue to fuel concerns around the barriers to adoption,” Leerink Swann analyst Danielle Antalffy says. Read More

A Medicare national coverage decision issued Wednesday should spur uptake of Thoratec’s HeartMate II left ventricular assist device at additional cardiac care centers across the U.S., company officials say. Read More

The U.S. Court of Appeals for the Federal Circuit has affirmed a lower court decision that found Synthes’ ’270 spinal implant patent invalid for lack of written description. Read More

King Systems has received an FDA warning letter over process validation, in-process testing, complaint handling and storage procedures. Read More

Abbott got a long-awaited green light on its MitraClip device for mitral regurgitation. Read More

Revised government policy would effectively end the use of many metal-on-metal hip replacements in UK public hospitals. Read More

Don’t blame wide variations in hospital charges on differences in the costs of devices, a new report concludes. Read More

Revisions to the FDA’s Regulatory Procedures Manual don’t add any clarity on when a product removal is a recall and when it’s a market withdrawal, attorneys say. Read More

Medtronic expects smooth sailing for its CoreValve transcatheter aortic valve PMA, after the FDA took the rare step of saying clinical trial data on extreme-risk patients is so compelling that an advisory panel meeting won’t be needed. Read More